NEW YORK — Diagnostic equipment manufacturer Opti Medical Systems said on Thursday that its SARS-CoV-2 test kit has received Emergency Use Authorization from the US Food and Drug Administration.
The Opti SARS-CoV-2 RT-PCR kit is designed to detect viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs, bronchoalveolar lavage, and sputum samples. It provides results within three and a half hours, the company said.
"We have validated the OPTI SARS-CoV-2 RT-PCR test kit with existing laboratory customers and are advancing our initial distribution to select certified laboratories using common PCR platforms," Opti Corporate Vice President and General Manager Olivier te Boekhorst said in a statement.
Roswell, Georgia-based Opti is a subsidiary of Idexx Laboratories.